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Insulin glargine U300 HOE901

Phase 3

Diabetes Mellitus Type 2 | Small molecule | Metabolic |Sanofi|Last Updated: Dec 3, 2014

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

Insulin glargine U300 HOE901 · 1 trial · 1 indication

Phase 3 1
NCT02227212Ease of Use and Safety of the New U300 Pen Injector in Insulin-Naïve Patients With T2DMDiabetes Mellitus Type 2
COMPLETED40 Analytics
PHASE3COMPLETED
Ease of Use and Safety of the New U300 Pen Injector in Insulin-Naïve Patients With T2DM
Diabetes Mellitus Type 2
NCT0222721240
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Study Endpoints

Primary Endpoints

Ease-of-use / ease of learning questionnaire
Day 1, Day 7 , 4-weeks

Secondary Endpoints

Change in treatment satisfaction score (sum of items 1, 4, 5, 6, 7, and 8 from Diabetes Treatment Satisfaction Questionnaire [status]) from baseline to Week 4
Baseline, week 4
Change in perception of hyper- and hypoglycemia score (items 2 and 3 from Diabetes Treatment Satisfaction Questionnaire [status]) from baseline to Week 4
Baseline, week 4
Change in fasting plasma glucose (FPG) (mmol/L) from baseline to Week 4
Baseline, week 4
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Insulin glargine U300EXPERIMENTALOnce daily subcutaneous injection for 4 weeks

Interventions

NameTypeDescription
Insulin glargine U300 (new formulation of insulin glargine) HOE901DRUGPharmaceutical form:solution for injection Route of administration: subcutaneous
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion criteria: * Patients with T2DM inadequately controlled with non-insulin, non-injectable anti-hyperglycemic drug(s) and for whom the Investigator/treating physicians has decided that basal insulin is appropriate. * Signed written informed consent. Exclusion criteria: * Glycated hemoglobi...

Countries:Germany
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